Apixaban compared to heparin/vitamin K antagonist in patients with atrial fibrillation scheduled for cardioversion: the EMANATE trial.
Apixaban compared to heparin/vitamin K antagonist in patients with atrial fibrillation scheduled for cardioversion: the EMANATE trial.
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DOI：
10.1093/eurheartj/ehy148
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发表时间：
2018-08-21
影响因子：
39.3
通讯作者：
Kirchhof P
中科院分区：
文献类型：
--
作者：
Ezekowitz MD;Pollack CV Jr;Halperin JL;England RD;VanPelt Nguyen S;Spahr J;Sudworth M;Cater NB;Breazna A;Oldgren J;Kirchhof P
主要目的是比较阿哌沙班与肝素/维生素K拮抗剂（VKA）在随机化接受心脏复律前抗凝≤48小时的房颤（AF）患者中的疗效。1500例患者接受了随机化。阿哌沙班剂量为5 mg b.i.d.降至2.5 mg b.i.d.。符合以下两项的患者：年龄≥ 80岁、体重≤ 60 kg或血清肌酐≥ 133 µmol/L。为了加快心脏复律，根据研究者的判断，允许进行成像和/或负荷剂量10 mg（下调至5 mg）。疗效终点为卒中、全身性栓塞（SE）和死亡。安全性终点为大出血和临床相关非大出血（CRNM）。有1038例主动复律和300例自发复律; 162例患者未复律。在855名患者中进行了成像，342名患者接受了阿哌沙班的负荷剂量。在全分析集中比较阿哌沙班与肝素/VKA，卒中发生率为0/753 vs. 6/747 [相对风险（RR）0; 95%置信区间（95% CI）0-0.64;标称P = 0.015]，无SE，死亡发生率为2 vs. 1（RR 1.98; 95% CI 0.19-54.00;标称P > 0.999）。在安全性人群中，分别有3/735 vs. 6/721例严重（RR 0.49; 95% CI 0.10-2.07;标称P = 0.338）和11 vs. 13例CRNM出血事件（RR 0.83; 95% CI 0.34-1.89;标称P = 0.685）。在影像学检查中，60/61例血栓患者继续接受随机治疗;所有（61例）患者均未发生结局事件。接受心脏复律的阿哌沙班和肝素/VKA治疗AF患者的卒中、全身性栓塞、死亡和出血发生率均较低。NCT02100228
The primary objective was to compare apixaban to heparin/vitamin K antagonist (VKA) in patients with atrial fibrillation (AF) and ≤48 h anticoagulation prior to randomization undergoing cardioversion. One thousand five hundred patients were randomized. The apixaban dose of 5 mg b.i.d. was reduced to 2.5 mg b.i.d. in patients with two of the following: age ≥ 80 years, weight ≤ 60 kg, or serum creatinine ≥ 133 µmol/L. To expedite cardioversion, at the discretion of the investigator, imaging and/or a loading dose of 10 mg (down-titrated to 5 mg) was allowed. The endpoints for efficacy were stroke, systemic embolism (SE), and death. The endpoints for safety were major bleeding and clinically relevant non-major (CRNM) bleeding. There were 1038 active and 300 spontaneous cardioversions; 162 patients were not cardioverted. Imaging was performed in 855 patients, and 342 received a loading dose of apixaban. Comparing apixaban to heparin/VKA in the full analysis set, there were 0/753 vs. 6/747 strokes [relative risk (RR) 0; 95% confidence interval (95% CI) 0–0.64; nominal P = 0.015], no SE, and 2 vs. 1 deaths (RR 1.98; 95% CI 0.19–54.00; nominal P > 0.999). In the safety population, there were 3/735 vs. 6/721 major (RR 0.49; 95% CI 0.10–2.07; nominal P = 0.338) and 11 vs. 13 CRNM bleeding events (RR 0.83; 95% CI 0.34–1.89; nominal P = 0.685). On imaging, 60/61 with thrombi continued randomized treatment; all (61) were without outcome events. Rates of strokes, systemic emboli, deaths, and bleeds were low for both apixaban and heparin/VKA treated AF patients undergoing cardioversion. NCT02100228
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